Phase 3
Completed N=305
Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)
Source: ClinicalTrials.gov NCT01730053 ↗Enrolled (actual)
305
Serious AEs
7.2%
Results posted
Oct 2015
Primary outcomePrimary: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis — -16.3; -14.4; -50.6; -15.9 percent change — p=<0.0001
Summary
To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia at high cardiovascular (CV) risk.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis |
-16.3; -14.4; -50.6; -15.9; -11.0; -36.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis |
-18.3; -20.3; -53.5; -17.0; -16.5; -41.5 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis |
-17.1; -17.4; -49.6; -22.1; -19.3; -32.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis |
-17.2; -20.3; -52.6; -22.9; -21.8; -35.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis |
-7.3; -9.7; -36.5; -9.8; -11.2; -28.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis |
-8.8; -11.2; -39.5; -12.7; -12.6; -30.4 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis |
-11.3; -13.4; -42.7; -11.2; -12.9; -31.4 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis |
-12.9; -17.5; -45.7; -14.9; -18.2; -35.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis |
-8.3; -8.7; -28.9; -8.5; -12.4; -20.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 12 - ITT Analysis |
-8.1; -12.1; -36.1; -13.7; -14.3; -29.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis |
-11.7; -16.3; -41.2; -18.0; -18.7; -29.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total-C at Week 12 - ITT Analysis |
-8.9; -11.8; -29.0; -13.8; -13.9; -19.4 | <0.0001 sig |
| SECONDARY Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis |
45.0; 57.2; 84.9; 40.1; 52.2; 66.7 | <0.0001 sig |
| SECONDARY Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis |
47.0; 60.5; 86.4; 41.3; 54.8; 70.4 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis |
31.3; 43.1; 77.8; 29.9; 43.6; 60.1 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis |
34.8; 46.7; 76.5; 30.6; 45.1; 66.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis |
-4.0; -4.3; -27.9; -5.2; -5.8; -22.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis |
1.7; 4.0; 9.1; 1.5; -1.8; 7.2 | =0.0311 sig |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis |
-1.8; -8.3; -11.2; -9.9; -11.1; -8.7 | — |
| SECONDARY Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis |
5.4; 5.0; 6.7; 2.9; -0.9; 6.7 | — |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis |
-0.7; -3.9; -20.7; 3.5; 7.9; -16.0 | — |
| SECONDARY Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis |
0.7; 0.2; 5.9; 0.6; 3.1; 8.0 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis |
8.1; -8.2; -14; -2.7; -12.4; -10.1 | — |
| SECONDARY Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis |
4.0; 2.6; 4.3; 0.9; 1.8; 9.1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with LDL-C greater than or equal to 70 mg/dL at the screening visit and who are not adequately controlled with a stable daily dose of rosuvastatin, with or without other LMT.
OR
- Patients with screening LDL-C greater than or equal to 100 mg/dL who are not adequately controlled with a stable daily dose of rosuvastatin before the screening visit, with or without other LMT.
Exclusion Criteria
- LDL-C less than 70 mg/dL at the screening visit in patients with history of documented cardiovascular disease (CVD)
- LDL-C less than 100 mg/dL at the screening visit in patients without history of documented coronary heart disease (CHD) or non-CHD CVD, but with other risk factors
- Homozygous familial hypercholesterolemia (FH) (clinically or previous genotyping)
- Recent (within 3 months prior to the screening visit) myocardial infarction (MI), unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease
- Newly diagnosed (within 3 months prior to randomization visit) or poorly controlled diabetes
- Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
(The inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).
Data sourced from ClinicalTrials.gov (NCT01730053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.